NCT04318860

Brief Summary

This study aimed to evaluate pain after elective colorectal surgery and to identify risk factors for postoperative pain. Patients:All elective colorectal surgeries at the department of surgery, Umeå university Hospital, Umeå, Sweden from March 2013 to April 2017 Primary outcome:The primary outcome measurement is the numeric rating scale (NRS), graded from 0-10, on day of surgery, postoperative (POD) 1, 2, 3. The patients are questioned by nurses each morning on four postoperative days to score the maximum pain during the previous 24 hours using the NRS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
Last Updated

March 24, 2020

Status Verified

August 1, 2019

Enrollment Period

4 years

First QC Date

March 17, 2020

Last Update Submit

March 23, 2020

Conditions

Postoperative Pain

Keywords

Postoperative painColorectal surgeryNumeric rating scaleMinimally invasive surgeryRisk factors

Outcome Measures

Primary Outcomes (4)

  • Maximum pain on day of surgery

    Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)

    Day of surgery

  • Maximum pain on postoperative day 1

    Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)

    Postoperative day 1

  • Maximum pain on postoperative day 2

    Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)

    Postoperative day 2

  • Maximum pain on postoperative day 3

    Numeric rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain)

    Postoperative day 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adults undergoing elective colorectal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Surgery, Inst of Surgical and Perioperative sciences

Umeå, Umea, 901 85, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Karl A Franklin, prof

    Dept Surgical and periopertive sciences, Umeå university, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 24, 2020

Study Start

March 15, 2013

Primary Completion

April 1, 2017

Study Completion

October 1, 2017

Last Updated

March 24, 2020

Record last verified: 2019-08

Locations

SE(1)